PregnancyNCT01974050
PregText: Feasibility of Monitoring Influenza Vaccine Safety in Pregnant Women Using Text Messaging
A study testing Text message surveillance in people with Pregnancy, run by Columbia University at 1 site in United States.
Trial summary
In this study, the investigators will prospectively assess fever rates and other adverse events in pregnant women after administration of inactivated influenza vaccine (IIV) using text messaging. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Text message surveillance
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are pregnant with a gestational age of <20 weeks either by last menstrual period (LMP) and/or ultrasound
- Are at least 18 years of age
- Have a visit at a study site during the enrollment period
- Receive IIV at that visit
- Have a cell phone with text messaging capabilities
- Are English or Spanish-speaking
- Are willing to report via text message through end of pregnancy
Who cannot join
- Decision to not continue with pregnancy
- Any contraindication to receipt of inactivated influenza vaccines
- Receipt LAIV (live attenuated influenza vaccine) at that visit
- Previous receipt of IIV in this pregnancy
- Presence of fever >=100.4F at time of vaccination;
- Administration of any antipyretic in the 6-hour period prior to vaccination,
Show all 10Show fewer
- Stated intent, at time of vaccination, to use prophylactic antipyretics before the development of a fever;
- Patient only speaks a language other than English or Spanish
- Patient does not have a cell phone with text messaging
- Patient's inability to read text messages
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PregText: Assessing the Feasibility of Monitoring Influenza Vaccine Safety in Pregnant Women Using Text Messaging
In this study, the investigators will prospectively assess fever rates and other adverse events in pregnant women after administration of inactivated influenza vaccine (IIV) using text messaging. The investigators hypothesize that women <20 weeks gestational age who receive IIV will be willing to enroll in a text messaging-based vaccine adverse event monitoring program and will use it to report fever in the post-vaccination period as well as continue to text pregnancy-related outcomes through the end of their pregnancy.
- Conditions
- Pregnancy
- Being tested
- Text message surveillance
- Keywords
- Influenza vaccination
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text message surveillanceBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Text message monitoring | Other | Use of text messaging to monitor post-vaccination Receives: Behavioral: Text message surveillance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Recruited Eligible Pregnant Women <20 Weeks Gestational Age
Number of eligible pregnant women <20 weeks gestational age who receive IIV who will be willing to enroll in a text messaging-based vaccine adverse event monitoring program
Measured: 3 months
Secondary outcomes (2)
Number of Participants Who Replied to Text Messaging to Assess Fever Frequency in the d0-2 Post-vaccination With IIV
Number of enrollees who text temperature-related information for the d0-2 period post-vaccination
Measured: on vaccination day and the next 2 days (D0-2)
Number of Women Enrollees Who Continue to Text Pregnancy-related Outcomes Through the End of Pregnancy
Feasibility of text messaging to monitor pregnancy outcomes through the end of pregnancy: Number of women enrollees who continue to text pregnancy-related outcomes through the end of their pregnancy
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2014
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Responsible party
- Principal investigator, Melissa Stockwell, Columbia University
- Investigators
- Melissa Stockwell, MD MPH, Principal investigator, Columbia UniversityPhilip LaRussa, MD, Principal investigator, Columbia UniversityMaria Cano, MD MPH, Principal investigator, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01974050
- Sponsor's protocol ID
- AAAM4906
- Status last verified
- Feb 2018
- First submitted
- 28 Oct 2013
- Last updated
- 12 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Stockwell MS, Cano M, Jakob K, Broder KR, Gyamfi-Bannerman C, Castano PM, Lewis P, Barrett A, Museru OI, Castellanos O, LaRussa PS. Feasibility of Text Message Influenza Vaccine Safety Monitoring During Pregnancy. Am J Prev Med. 2017 Sep;53(3):282-289. doi: 10.1016/j.amepre.2017.03.014. Epub 2017 May 8.
PubMed 28495223
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PregText: Assessing the Feasibility of Monitoring Influenza Vaccine Safety in Pregnant Women Using Text Messaging
- ClinicalTrials.gov ID
- NCT01974050
- Acronym / sponsor ID
- AAAM4906
- Conditions
- Pregnancy
- Keywords
- Influenza vaccination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Nov 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 1 Nov 2013 (estimated)
- Results
- Posted 9 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, the investigators will prospectively assess fever rates and other adverse events in pregnant women after administration of inactivated influenza vaccine (IIV) using text messaging. The investigators hypothesize that women <20 weeks gestational age who receive IIV will be willing to enroll in a text messaging-based vaccine adverse event monitoring program and will use it to report fever in the post-vaccination period as well as continue to text pregnancy-related outcomes through the end of their pregnancy.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Text message monitoring | Other | Behavioral: Text message surveillanceUse of text messaging to monitor post-vaccination |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Are pregnant with a gestational age of <20 weeks either by last menstrual period (LMP) and/or ultrasound
- Are at least 18 years of age
- Have a visit at a study site during the enrollment period
- Receive IIV at that visit
- Have a cell phone with text messaging capabilities
Key exclusion criteria (10 listed)
- Decision to not continue with pregnancy
- Any contraindication to receipt of inactivated influenza vaccines
- Receipt LAIV (live attenuated influenza vaccine) at that visit
- Previous receipt of IIV in this pregnancy
- Presence of fever >=100.4F at time of vaccination;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Text message surveillance | Behavioural | Text message monitoring |
Primary outcome
Number of Recruited Eligible Pregnant Women <20 Weeks Gestational Age
Time frame: 3 months
Number of eligible pregnant women <20 weeks gestational age who receive IIV who will be willing to enroll in a text messaging-based vaccine adverse event monitoring program
2 secondary outcomes
Number of Participants Who Replied to Text Messaging to Assess Fever Frequency in the d0-2 Post-vaccination With IIV
Time frame: on vaccination day and the next 2 days (D0-2)
Number of Women Enrollees Who Continue to Text Pregnancy-related Outcomes Through the End of Pregnancy
Time frame: 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28495223Stockwell MS, Cano M, Jakob K, Broder KR, Gyamfi-Bannerman C, Castano PM, Lewis P, Barrett A, Museru OI, Castellanos O, LaRussa PS. Feasibility of Text Message Influenza Vaccine Safety Monitoring During Pregnancy. Am J Prev Med. 2017 Sep;53(3):282-289. doi: 10.1016/j.amepre.2017.03.014. Epub 2017 May 8.
- PubMed linkLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Melissa Stockwell, MD MPH principal investigator
Columbia University
Philip LaRussa, MD principal investigator
Columbia University
Maria Cano, MD MPH principal investigator
Centers for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text message surveillance in people with Pregnancy, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Recruited Eligible Pregnant Women <20 Weeks Gestational Age (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01974050, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2018.